In December 2020, the American Red Cross, OneBlood and Vitalant, together representing over 50% of the blood supply in the United States, initiated the ADVANCE (Assessing Donor Variability And New Concepts in Eligibility) Study. ADVANCE was a pilot study funded by a contract from the US Food and Drug Administration (FDA) that could potentially lead to a significant change to the 3-month blood donor deferral policy for men who have sex with other men (MSM). The study was designed to assess whether a donor deferral based on gender-neutral risk-factor behavioral questioning could be used in place of a time-based deferral while maintaining the safety of the blood supply.
Over the course of 21 months, ADVANCE research staff recruited and enrolled over 1,500 participants in total from eight cities around the US – Washington, DC, Los Angeles, San Francisco, Memphis, New Orleans/Baton Rouge, Atlanta, Orlando, and Miami. Participants completed numerous questionnaires about their sexual behaviors, feelings about donation, and use of pre- and/or post-exposure prophylaxis (PrEP and PEP, respectively). They also completed a blood draw which was sent for HIV testing and PrEP detection. Responses to the questionnaires were compared to the results of testing to determine if questions can be used to identify subjects with early HIV infection or those on PrEP. Following completion of the study enrollment and follow-up period, results were shared with the FDA for them to determine if a change in donor eligibility would be possible.
In late January 2023, the FDA released new draft guidance which proposes a shift from time-based deferral to an individual behavioral risk assessment as protections for the US blood supply against risk of HIV. The new guidance proposes:
- All prospective donors, regardless of gender identity, will be asked if they have had a new partner or more than one partner in last three months.
- Those who report a new or more than one partner in the past three months would then be asked about anal intercourse in past 3 months
- All donors, regardless of gender identity, who report a new partner or more than one partner AND anal intercourse in the past 3 months would be deferred for 3 months from the most recent sexual contact.
- Any individual who has ever had a positive test for HIV or has ever taken any medication to treat an HIV infection would continue to be deferred permanently.
- Individuals who are taking medications to prevent HIV infection, such as PrEP, would be deferred.
- Oral PrEP or PEP – deferred 3 months from last dose
- Injectable PrEP – deferred 2 years from last injection
The FDA acted swiftly following the conclusion of the ADVANCE Study and focused its proposed changes on what would be feasibly implemented at all US blood centers. They used data from ADVANCE, serosurveillance programs such as the Transfusion-Transmissible Infections Monitoring System (TTIMS), performance characteristics of nucleic acid testing, as well as data from other countries with similar HIV epidemiology (e.g., the United Kingdom and Canada) to make this decision. Subsequent press conferences and meetings with the FDA have suggested that further movement in the deferral for MSM are possible – for example for partners of virally suppressed individuals as well as those who take PrEP. However, more scientific advances in testing and additional studies may be needed for these changes to occur. Despite further movement on the deferrals that may happen in the future, the proposed changes to the number of new donors who will be eligible to donate blood because of the draft guidance is encouraging.
This Red Cross Month we celebrate these positive changes in blood donor eligibility, look forward to welcoming many new donors from the LGBTQ+ community into the life-saving act of donating blood, and thank those involved with serosurveillance activities, the ADVANCE Study, and other advocates who have pushed for more inclusive policies over the years.